HIV New guidelines issued for test

Public health clinics have recorded at least 49 false positives in San Francisco.
SAN FRANCISCO CHRONICLE
Federal health authorities plan to issue new guidelines on the use of an oral HIV test after testing centers in New York and San Francisco began reporting an unusual number of false positives in recent months.
Approved by the Food and Drug Administration in March 2004, the OraQuick Advance test shows results within 20 minutes using fluids swabbed from the mouth, a breakthrough in easy-to-use HIV testing that is being considered for over-the-counter sales to consumers.
However, public health clinics in San Francisco have now recorded at least 49 instances since May in which clients tested positive on the oral HIV test, but subsequent confirmation tests showed they were negative.
In New York City, clinics encountered a sudden increase in false positives with the oral test -- recording 10 in October and 30 in November alone, according to a San Francisco health official.
Dr. Bernard Branson, associate director for Laboratory Diagnostics at the Centers for Disease Control and Prevention in Atlanta, said the federal agency will issue an advisory that clinics offer patients who test positive on the oral test an immediate rapid retest using a droplet of blood.
"What we intend to suggest is that if someone is tested with oral fluid and is positive, that person -- if it is possible at the clinic -- should get a finger stick test," he said.
Have results confirmed
Even if the blood test is negative, the person will still need to have the results confirmed by more sophisticated Western Blot laboratory tests -- a process that can take a week -- but he or she can go home with much greater assurance that the initial oral test was probably erroneous.
Clinics that are able to draw blood using the finger stick method can use the same OraQuick product, which is licensed to process oral fluid, blood droplets or blood drawn into a test tube. The finger stick test also produces results in 20 minutes, and no comparable reliability issues for it have been raised.
Branson said the advisory is likely to be issued in this week's edition of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention's epidemiology bulletin.